Drug shortage led to spike in kids' infections

When there was a shortage of a drug used to prevent IV-related infections in kids, the frequency of those infections increased almost ten-fold at one Michigan hospital, a new study shows.

Known as ethanol lock therapy, the preventive drug is given to kids with bowel problems who require an IV feeding line because their intestines don't absorb enough nutrients.

Those children are at higher risk of infection to begin with because their gut bacteria don't have as much practice killing off germs, researchers said.

Luitpold Pharmaceuticals, then the sole supplier of ethanol, or dehydrated alcohol, voluntarily stopped manufacturing the drug between April and September, 2011 after scrutiny of pharmaceutical facilities by the U.S. Food and Drug Administration.

The details of the production halt were not made public.

Up until early 2011, kids being treated at C.S. Mott Children's Hospital in Ann Arbor were given daily ethanol lock therapy in their catheters to prevent infection. But with the shortage, that was cut back to weekly prophylaxis for most young patients.

The new study, published this week in Pediatrics, covers eight children ranging in age from 22 months to 18 years who'd been diagnosed with necrotizing enterocolitis or other intestinal conditions requiring an IV line.

When ethanol was readily available, there was an average of one catheter-related infection per child every four years.

But when the dosing frequency dropped, seven of the eight children developed catheter-related infections in just a few months. Six of them needed to be hospitalized as a result and spent more than two weeks in the hospital, on average. Treating them cost over $100,000 per patient, and two of the youths ended up in the intensive care unit.

"We definitely had concerns that rationing (ethanol) or decreasing the amount of time we used it could lead to an increase in infection," said lead author Dr. Matthew Ralls, from Mott and the University of Michigan Medical School.

But the researchers said the spike in infections was far greater than what they'd expected.

"We had basically a complete failure in prophylaxis," Ralls told Reuters Health. "We reverted back to the numbers from before we even used ethanol."

He said he and his colleagues hope that in the future, the FDA can come to an agreement with companies that are the sole producers of important drugs to only shut down some of their production facilities at any given time, for example.

"This had a profound effect on these kids," Ralls said. "Some of the complications were pretty devastating for some of these children."

A press officer at the FDA said the agency hadn't reviewed the new study.

But, Sarah Clark-Lynn told Reuters Health in an email, "the FDA is working hard with pharmaceutical companies to prevent and resolve drug shortages. Drug shortages (are) a top priority issue for the FDA and we are working hard to help assure that patients in the United States have access to the high quality medications they need."

She added that another company, Akorn Pharmaceuticals, is now manufacturing ethanol lock therapy. "We do not anticipate any further shortage issues at this time for this drug," she said.